Severe diabetic ulcers are often a complication of diabetes and are characterized as having a wound that penetrates the subcutaneous fat layer and ischemia. Approximately 18 million people in the U.S have diabetes and over 800,000 new cases are diagnosed each year. A significant percentage of those with diabetes, about 2.7 million, develop ulcers, e.g. foot ulcer. Of those with ulcers, about 1.2 million will develop a severe diabetic ulcer. Severe diabetic ulcers too often lead to infection, gangrene, amputation, and sometimes morbidity. In fact, diabetes is the most common underlying cause of lower extremity amputation in the United States and Europe.
Severe diabetic ulcers are difficult to treat as is evidenced by the high percentage of ulcers that result in amputation. Severe diabetic ulcers are extremely complex to treat having multiple, overlapping complications that impede or completely inhibit the patients healing process, e.g., ischemia, open and deep wound, infection, etc. The therapies presently on the market are typically designed for all types of wounds and do not adequately address the problematic issues of complex wounds, such as severe diabetic ulcers.
As evidenced above, a need exist for an improved method for treating severe diabetic ulcers specifically to reduce and/or prevent amputation. The present invention addresses this need and provides a method of successfully treating severe diabetic ulcers to induce healing and to prevent multiple amputations of the extremities of the diabetic patient.